ComplianceOnline, San Francisco
2019-04-22
The objective of this two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn which are available and to confirm that those that you are using are being used correctly. USP documents that will be reviewed include: - USP<51> Antimicrobial Effectiveness Testing
- USP<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
- USP<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- USP<71> Sterility Tests
- USP<1072> Disinfectants and Antiseptics
- USP<1111> Microbiological Examination of Nonsterile Products
- USP<1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products
- USP<1113> Microbial Characterization, Identification, and Strain Typing
- USP<1116> Microbiological Control and Monitoring of Aseptic Processing Environments
Various team exercises will be conducted to allow the participants to use these USP documents to solve "real life" problems. Plan to bring a cross-functional group of your personnel to attend this invaluable two day seminar. Learning Objectives:- Understanding the various General and General Information USP Chapters that apply to microbiology
- The focus of the chapters to include those that primarily involve non-sterile and sterile applications
- Chapters that involve the environment
- Examining the changes within the various Chapters that have recently occurred and how to interpret them
- Review areas that are often overlooked
- Study issues that continue to exist between the USP, EP and JP (harmonization)
- Examine the new regulatory attitude that is occurring with non-sterile products
- What now constitutes a "specified" and "objectionable" microorganism
- Explore Form FDA 483s and Warning Letters for microbiological applications
Who Will Benefit:- Manufacturing
- Product Development
- Project Management
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Regulatory Compliance
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Invited Speakers:
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Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations an ComplianceOnline d fermentation technology. Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international. Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide. Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.
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